Class II · Moderate risk Terminated
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc…
Reason SubPotent: Out of Specification
Is Orange recalled?
59 FDA recalls mention Orange. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Orange.
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile…
Reason Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing…
Class II · Moderate risk Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite…
Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of…
Class II · Moderate risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl…
Reason Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the…
Class I · High risk Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite…
Reason Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth…
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl…
Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a…
Class II · Moderate risk Terminated
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by…
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl…
Reason Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative…
Class I · High risk Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite…
Reason Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage…
Class I · High risk Terminated
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange…
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk Terminated
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging…
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2…
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count…
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class III · Low risk Terminated
AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class II · Moderate risk Terminated
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by…
Reason Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk Terminated
Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC…
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC…
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I · High risk Terminated
NET Remedies #6 (Orange Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET…
Reason Microbial contamination
Class I · High risk Terminated
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The…
Reason Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the…
Class III · Low risk Terminated
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown…
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code…
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Class I · High risk Terminated
Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an…
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